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Long-term efficacy and safety of agomelatine in non-depressed out-patients with generalized anxiety disorder. A 26-week randomised double-blind placebo-controlled parallel group study following an open-label period of 16 weeks with agomelatine (25 mg/day with the possibility for blinded dose-adjustment to 50 mg/day)

Condition category

Mental and Behavioural Disorders

Date applied

24/09/2007

Date assigned

26/03/2008

Last edited

18/04/2018

Prospective/Retrospective

Retrospectively registered

Overall trial status

Completed

Recruitment status

No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Primary contact

ORCID ID

Contact details

Additional identifiers

EudraCT number

2006-005674-47

ClinicalTrials.gov number

Protocol/serial number

CL3-20098-050

Study information

Scientific title

Long-term efficacy and safety of agomelatine in non-depressed out-patients with Generalized Anxiety Disorder.A 26-week randomised double-blind placebo-controlled parallel group study following an open-label period of 16 weeks with agomelatine (25mg/day with the possibility for blinded dose-adjustment to 50mg/day).

Acronym

Study hypothesis

To assess the efficacy of agomelatine in the prevention of relapse in non-depressed out-patients with Generalized Anxiety Disorder (GAD) after an initial response to agomelatine.

Overall trial start date

Overall trial end date

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged over 18 years 2. Out-patients of both genders3. Fulfilling the Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV) criteria for GAD

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

370

Participant exclusion criteria

1. Women of childbearing potential without effective contraception2. Patients meeting DSM-IV-TR current diagnosis of psychiatric disorder other than GAD3. Any clinically relevant abnormality detected during the physical examination, ECG or laboratory tests likely to interfere with the study conduct or evaluations

Funders

Funder type

Funder name

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Summary results are published in https://clinicaltrials.servier.com.For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.

IPD sharing plan: The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.